NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041220160

Registered date:14/03/2023

AN OPEN-LABEL CONTINUATION STUDY FOR PARTICIPANTS CONTINUING FROM ENCORAFENIB/BINIMETINIB CLINICAL STUDIES

Basic Information

Recruitment status Pending
Health condition(s) or Problem(s) studiedLocally advanced unresectable or metastatic melanoma with BRAFV600 mutation and previously untreated
Date of first enrollment10/03/2023
Target sample size3
Countries of recruitmentCanada,Japan,US,Japan,Belgium,Japan,Spain,Japan,France,Japan,Italy,Japan,Netherland,Japan,UK,Japan,Australia,Japan,Brazil,Japan,Czech Republic,Japan,Germany,Japan,Hungary,Japan,Israel,Japan,South Korea,Japan,Portugal,Japan,Russia,Japan,Slovakia,Japan
Study typeInterventional
Intervention(s)Encorafenib: [W00090 GE 2 01 Study] Encorafenib 300 mg (4 x 75 mg) QD, orally. [C4221004 Study] Encorafenib 300 mg or 450 mg QD, orally. Binimetinib: [W00090 GE 2 01 Study] Binimetinib 45 mg (3 x 15 mg) BID, orally. [C4221004 Study] Binimetinib 45 mg BID, orally. Cetuximab: [W00090 GE 2 01 Study] Cetuximab 400 mg/m2 or 500 mg/m2, IV, Q2W.

Outcome(s)

Primary Outcome1. AEs leading to permanent discontinuation of study intervention 2. All SAEs
Secondary Outcome

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderBoth
Include criteria1. Any participant who is receiving study intervention and deriving clinical benefit (as determined by the principal investigator) in an encorafenib/binimetinib Parent Study, with no ongoing NCI CTCAE version 4.03 Grade 3 or more or intolerable Grade 2 AEs considered to be related to study treatment. 2. Participants must agree to follow the reproductive criteria as outlined in Appendix 4 (Section 10.4.1 for males and Section 10.4.2 for females) of the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, and other study procedures as outlined in the applicable Encorafenib/Binimetinib Continuation Sub-Study Protocol. 4. Capable of giving signed informed consent as described in Appendix 1, Section 10.1.3, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclude criteria1. Any medical reason that, in the opinion of the investigator or sponsor, precludes the participant from inclusion in the study.

Related Information

Contact

Public contact
Name Kosuke Oki
Address Nakanoshima Daibiru 16F, 3-3-23, Nakanoshima, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-6116
Telephone +81-6-4560-6869
E-mail Kosuke.Oki@ppd.com
Affiliation PPD-SNBL K.K.
Scientific contact
Name Kosuke Oki
Address Nakanoshima Daibiru 16F, 3-3-23, Nakanoshima, Kita-ku, Osaka-shi, Osaka Osaka Japan 530-6116
Telephone +81-6-4560-6869
E-mail Kosuke.Oki@ppd.com
Affiliation PPD-SNBL K.K.